Kava, the widely used anti-anxiety herb that had been among the top ten herbs sold in Europe and North America, continues to be a subject of scrutiny and regulation based on allegations that some incidents of liver damage occurred as a result of using the herb extracts. There are significant questions about the reports of adverse effects. The cover story for the recent issue of Herbalgram (#55), Kava: Safety questions reviewed, comes with the subheading "Expert analysis of case reports say insufficient evidence to make causal connection." Still, regulators are worried about being blamed for taking steps too late if there is a real health risk to some users. Most recently, a ban went into effect in Canada, following closely on the heels of similar actions in several European countries. The American Herb Products Association (AHPA) has relayed the information succinctly as follows, including information about the current status of the herb in the U.S.:
Canada's health agency yesterday issued a "stop-sale order" for all products containing the herb kava. In a press release announcing this action, Health Canada stated that they made their decision "after a safety assessment concluded there is insufficient evidence to support [kava products] safe use." In addition, Health Canada is requesting the "recall of these products from all levels of the market." AHPA has requested a copy of the safety assessment on which these actions were based. Here is a link to Health Canada's health advisory on kava:
The Canadian Health Food Association (CHFA), the trade association that represents the herbal products industry in Canada, expressed strong opposition to the decision in a press release issued today stating, "Canada's stop-sale order of all products containing Kava is completely unacceptable." CHFA charged that Health Canada made its decision without having discussed its assessment of kava with experts in the field of herbal medicine and without having any new evidence on which to base their decision.
In the U.S., where kava is still legally sold, the Food and Drug Administration (FDA) today informed AHPA that its position has not changed in light of yesterday's action by Health Canada. In a consumer advisory on kava issued on March 25, 2002, the Agency stated that it would "continue to investigate the relationship, if any, between the use of dietary supplements containing kava and liver injury." The FDA consumer advisory can be read in full at:http://www.cfsan.fda.gov/~dms/addskava.html
As [AHPA members] were informed on July 29, AHPA's Executive Committee developed a revised warning label for kava products such that labels of all products containing kava should bear one of the following substantially similar statements, or other substantially similar statement:
US FDA advises that a potential risk of rare, but severe, liver injury may be associated with kava-containing dietary supplements. Ask a healthcare professional before use if you have or have had liver problems, frequently use alcoholic beverages, or are taking any medication. Stop use and see a doctor if you develop symptoms that may signal liver problems (e.g., unexplained fatigue, abdominal pain, loss of appetite, fever, vomiting, dark urine, pale stools, yellow eyes or skin). Not for use by persons under 18 years of age, or by pregnant or breastfeeding women. Not for use with alcoholic beverages. Excessive use or use with products that cause drowsiness may impair your ability to operate a vehicle or heavy equipment.
US FDA advises that a potential risk of rare, but severe, liver injury may be associated with kava-containing dietary supplements. Ask a healthcare professional before use if you have or have had liver problems, frequently use alcoholic beverages, or are taking any medication. Stop use and see a doctor if you develop symptoms that may signal liver problems, including jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other nonspecific symptoms can include nausea, vomiting, light-colored stools, unexplained tiredness, weakness, stomach or abdominal pain, and loss of appetite. Not for use by persons under 18 years of age, or by pregnant or breastfeeding women. Not for use with alcoholic beverages. Excessive use, or use with products that cause drowsiness, may impair your ability to operate a vehicle or heavy equipment.
When AHPA first recommended a new kava label statement on March 26, 2002, AHPA members were encouraged to provide this new labeling as of their next print run of labels for kava products but not more than 6 months from that date, and that continues to be the suggested time frame. AHPA members that have already added the March 26th statement or a substantially similar statement to their label should consider the use of stickers to place the new first sentence onto their products. [end of AHPA alert]
In accordance with the original notification, products now being distributed by AHPA members are labeled with cautions, though some may have shortened versions due to space limitations. ITM included a caution statement about kava in its book A Bag of Pearls, in the April 2002 revised edition and provided a lengthy review of the kava situation in its May 2002 START Group mailing (Safety issues affecting herbs: the case of kava, which this articles now replaces).
The U.S. FDA is still investigating the situation and has not taken any steps to limit the import or distribution of kava. Product liability insurers have had variable responses, some attaching an exclusion for kava-containing products to their policies, others not taking action until more is known. The insurance industry can be highly influential; for example, an exclusion of coverage for ephedra (ma-huang) products has greatly reduced their availability, even though the U.S. FDA has taken no action against ephedra.
As a precautionary measure, ITM has discontinued inclusion of kava in two White Tiger formulas that were originally designed with this herb: Melakava and Nardova. There is no reason at this time to suspect that they are unsafe at the recommended dosages, especially if the cautions described above are followed. Indeed, millions of people have used kava with apparent safety over the past 30 years since it was elevated from a South Pacific traditional remedy to a world-wide natural health care product.
A small supply of the two White Tiger formulas will be available for those who have used the herb safely and rely on it. The bottles, produced earlier this year, can be obtained by practitioners until the end of 2002, or when the supply runs out, whichever comes first. Practitioners should evaluate their patients for safe use of these formulations. The warning labels suggested by AHPA apply to products intended for sale direct to consumers, and advise asking a healthcare professional; in this case, these prescription items will be prescribed with appropriate cautionary statements by the practitioner.
Replacement formulas have been designed and are in production, expected to be available by end of November: Melakava will be replaced by Melazandra, and Nardova will retain its original name, but is reformulated. In Melazandra, kava is substituted by the trio of schizandra, lily bulb, and polygala (the formula is intended to treat insomnia or jet lag), while in Nardova, kava is replaced by albizzia and the amino acid l-theanine, an anxiolytic component of tea (the formula is for anxiety, depression, and PMS, but can also be used for insomnia). Details of the new formulations appear on the following pages, in the same format as in the book A Bag of Pearls, and will appear in revised versions of the book. The dosage recommendation for Nardova has been adjusted slightly: the original formula recommendation was for 1 tablet each time, two times per day (or 1-2 tablets taken before bed); the current recommendation is also for 1 tablet each time, but for 2-4 times per day (or 1-2 tablets taken before bed, as before).